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Orthopedic Implant
Ankle Implant for Arthritis
N/A
Waitlist Available
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient is > 18 years of age
The patient is skeletally mature
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study Summary
This trial is testing the success of a new ankle implant. It will look at things like pain and function, quality of life, and how long the implant lasts.
Who is the study for?
This trial is for adults over 18 with arthritis (degenerative, rheumatoid, or post-traumatic) who need ankle replacement surgery. They must be able to consent and follow the study's procedures. Excluded are prisoners, those mentally unable to participate, non-compliant individuals, pregnant women, patients with infections or poor bone quality, and those with severe limb issues.Check my eligibility
What is being tested?
The Zimmer Trabecular Metal Total Ankle System is being tested in people needing ankle replacements due to arthritis. The study aims to track how well the implant works by looking at pain relief, improved function, life quality measures and checking x-rays for durability.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include pain at the implant site, swelling of the affected limb(s), infection risks around the new joint and possible allergic reactions if sensitive to materials used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
My bones have stopped growing.
Select...
I am eligible for an ankle replacement due to arthritis or injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survivorship
Secondary outcome measures
American Orthopaedic Foot and Ankle Society Score
Trial Design
1Treatment groups
Experimental Treatment
Group I: Zimmer TM Total Ankle SystemExperimental Treatment1 Intervention
Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System
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Who is running the clinical trial?
Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,275 Total Patients Enrolled
62 Trials studying Arthritis
13,646 Patients Enrolled for Arthritis
Kacy Arnold, RN MBAStudy DirectorZimmer Biomet
7 Previous Clinical Trials
744 Total Patients Enrolled
3 Trials studying Arthritis
700 Patients Enrolled for Arthritis
Erin Osborn, MBAStudy DirectorZimmer Biomet
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.I am not a prisoner, mentally competent, understand the study, and do not abuse substances.I have severe ankle issues or nerve/blood vessel diseases affecting my leg.I have an infection that could impact a joint replacement.My bones have stopped growing.I am eligible for an ankle replacement due to arthritis or injury.I am ready and can follow through with the needed therapy after surgery.My bones are too weak or damaged to support surgical implants.I have had an infection in my joint before.
Research Study Groups:
This trial has the following groups:- Group 1: Zimmer TM Total Ankle System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research actively recruiting participants?
"According to the data on clinicaltrials.gov, this research is not currently recruiting participants; however, it was last updated in October of 2022 and there are an additional 936 trials that are actively searching for volunteers."
Answered by AI
What is the geographic scope of this analysis?
"The present trial is recruiting participants at 6 centres, situated in Philadelphia, Charlotte and Vancouver among other places. To lessen any travelling demands that may arise from participation in the study, it would be prudent to choose a site closest to you."
Answered by AI
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